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NCT Number: NCT05603988

Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression

This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions.

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Key information

Conditions

Endodontically Treated Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 11553, Egypt

About this study

  • Thorough medical and dental history for the eligible patients
  • Thorough intraoral and extraoral diagnosis
  • Local anesthesia
  • Isolation and removal of any previous filling or restoration
  • Removal of old gutta percha and establish patency to the full working length.
  • 1st sample: will be collected using 3 sterile paper points
  • Chemo-mechanical preparation.
  • 2nd sample collection
  • Laser group: The canals will be irradiated with a high-power diode laser, with wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter.
  • Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation, but not activated.
  • 3rd sample collection
  • A piece of dry cotton will be placed in the access cavity, and then will be sealed with glass ionomer filling material
  • 2nd visit: 1 week later, 4th sample collection then Obturation
  • Number of visits & follow up period: Two visits

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected.
  • Teeth with straight root canals.
  • No contributory medical history.
  • No previous administration of analgesics and/or antibiotics within the previous 2 weeks.

Exclusion criteria

  • Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
  • Teeth with curved roots.
  • Swelling or sinus tract.
  • Mutilated teeth that interfere with proper isolation and seal between visits.
  • Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm.
  • Subjects with uncontrolled diabetes or debilitating diseases.
  • Pregnant or nursing females.
  • Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.

Treatment and study plan

Intracanal Diode laser irradiation

Device

After endodontic retreatment, root canals will be irradiated with a 980 nm diode laser coupled with optical fibre 200 μm (Litemedics, Italy) with setting 1.2-watt power, in pulsed mode. The irradiation protocol will be of 5-sec irradiation followed by a 10-sec pause, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. The tip will be positioned 1 mm short of the apex. Followed by activation during which it will be slowly dragged at a speed of approximately 2 mm/ sec in a way that the root canals will be irradiated from the apical to the coronal portion, in a helicoidal movement touching the canal walls.

Placebo

Other

After endodontic retreatment, mock laser application (Placebo group) will be applied:

The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated

Primary outcomes

  1. quantification of IL-8

    Time frame: one week

    • After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.

Secondary outcomes

  1. Postoperative pain

    Time frame: 6, 12, 24 hours and 7 days

    Following the first visit, the modified visual analogue scale (VAS scale) with 11 points where 0 means no pain and 10 means maximum pain will be used to record patient's level of pain

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression in Lesions Refractory to Endodontic Treatment: A Randomized Control Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2022
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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